BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA S STD FEMORAL STEM

    MDR report key: 1815153 · Received March 8, 2010

    Report

    Report Number
    3005180920-2010-00006
    Event Type
    Injury
    Date Received
    March 8, 2010
    Date of Event
    February 10, 2010
    Report Date
    February 11, 2010
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING RECORDS AND QUALITY DOCUMENTS WERE REVIEWED. THE MANUFACTURING AND QUALITY DOCUMENT REVIEW CONFIRMED THAT ALL IMPLANTS RELEASED TO THE FIELD OF LOT NUMBER 090012 (B)(4) CONFORM TO THE SPECIFICATION VALID AT THE TIME OF MANUFACTURE. THE FRACTURE IS NOT DEVICE RELATED AND IS A KNOWN COMPLICATION OF TOTAL HIP ARTHROPLASTY.

    Description of Event or Problem · 1

    THE SURGEON STARTED WITH THE STANDARD SIZE 0 JACOB BROACH AND CONTINUED BROACHING UP TO SIZE 6. WHILE BROACHING, THE MEDIAL CALCAR FRACTURED AND A CABLE WAS USED TO FIX THE FRACTURE. THE FINAL IMPLANT WAS A SIZE 6. THE PT WAS PUT ON RESTRICTED ACTIVITIES, LIMITING WEIGHT BEARING AND USING A WALKER. THERE IS NO ADDITIONAL MEDICAL INTERVENTION OR REVISION SURGERY EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUADRA S STD FEMORAL STEM FEMORAL STEM JDI MEDACTA INTERNATIONAL SA NA 090012

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention